NuVasive Announces PMA Approval of the PCM(R) Cervical Disc System
NuVasive (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for the PCM(R) Cervical Disc System. This novel device will be provided to patients and surgeons in the United States as an innovative option to preserve motion in the cervical spine instead of a traditional, motion-eliminating fusion procedure. The FDA approval comes after successful completion of a prospective, multicenter randomized investigational device exemption (IDE) clinical trial that was conducted at 23 investigational sites across the United States and included 403 total treated patients. Alex Lukianov, Chairman and Chief Executive Officer, said, "We are really pleased to offer this unique technology to the U.S. surgical
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